To sustain biomedical research activities and transition
into independence the core resources of Centers of Biomedical Research
Excellence (COBRE)

Key
Dates

Posted Date

May 31, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

August 2, 2013

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October/November 2013

Advisory Council Review

January 2014

Earliest Start Date

April 2014

Expiration Date

August 3, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in
the PHS 398
Application Guide except where instructed to do otherwise (in this FOA or
in a Notice from the NIH Guide
for Grants and Contracts). Conformance to all requirements (both in
the Application Guide and the FOA) is required and strictly enforced. While
some links are provided, applicants must read and follow all application
instructions in the Application Guide as well as any program-specific
instructions noted in Section IV. When
the program-specific instructions deviate from those in the Application Guide,
follow the program-specific instructions. Applications that do not
comply with these instructions may be delayed or not accepted for review.

Looking ahead: NIH is committed to transitioning all
grant programs to electronic submission using the SF424 Research and Related
(R&R) format and is currently investigating solutions that will accommodate
NIH’s multi-project programs. NIH will announce plans to transition the
remaining programs in the NIH
Guide to Grants and Contractsand on NIH’s Applying
Electronically website.

The Institutional Development Award (IDeA) Program endeavors
to stimulate research at institutions in states that have not traditionally
received significant levels of research funding from the NIH. Created through
congressional mandate, the IDeA Program broadens the geographic distribution of
NIH funding for competitive biomedical and behavioral research by enhancing the
research capabilities of institutions in eligible states. The IDeA Program aims
to achieve this goal through 2 major initiatives: (1) the IDeA Networks of
Biomedical Research Excellence (INBRE), and (2) the Centers of Biomedical
Research Excellence (COBRE).

The COBRE initiative seeks to develop unique, innovative,
multidisciplinary, and collaborative state-of-the-art biomedical and behavioral
research centers focused on a scientific theme that is nascent or only
minimally developed at applicant institutions. This is accomplished by
nurturing and expanding a critical mass of competitive biomedical research
investigators through intensive mentoring of emerging research faculty and aggressive
recruitment of seasoned investigators, and by enhancing the research
environment and infrastructure through the establishment of critical core resources.

COBRE support consists of three sequential five-year
phases. Phase I focuses on the development of requisite research resources and infrastructure,
and the provision of formal research mentoring and research project funding to
junior investigators to facilitate their acquisition of preliminary data and
successful competition for independent research grant support. Phase II is intended to
further strengthen the center through the support and enhancement of the growing
research infrastructure and continuing the development and expansion of a
critical mass of investigators with shared scientific interests. After ten
years of COBRE support, the centers and their aligned investigators are
expected to be able to compete successfully for other sources of research
funding, including individual and/or program project or center grants from
other NIH Institutes and Centers or other Federal and non-Federal entities.

COBRE Phase
III, the focus of this funding opportunity announcement, primarily provides
support for scientific and technical cores to become independent service
research facilities in the institution. It has the following objectives:

To facilitate the transition of research core resources developed
during phases I and II into sustainable state-of-the-art core facilities
capable of supporting the conduct of high-caliber biomedical research

To sustain the research environment developed in the first 2
phases by providing support for pilot research projects and mentoring and training
activities

Overall Center Organization and Management Plan

Applications for the COBRE Phase III Transitional Centers
can only come from active COBRE Phase II awardees. The application must
include infrastructure and/or activities that will support the following components:

Administrative Core

Core Resources and Facilities

Pilot Grants Program

Evidence of accomplishments during the past ten years of
COBRE support must be provided in the application. The organizational
structure of the center and the overall strategic plan must be well-defined,
including the scientific opportunities that will be pursued in the next 5 years
to further the thematic focus of the center. The application must clearly show
the need for support of proposed core resources that comprise the center and
provide the broad plans for promoting and ensuring their sustainability.
Crucial to the effective operations of the center is an administrative core
that oversees the coordination and facilitation of all research and training
activities supported by the COBRE cores. The Pilot Grants Program must be open
to investigators from a variety of disciplines and specialties with research
interests in the scientific theme of the COBRE.

Funds cannot be used at collaborative institutions in
non-IDeA states. However, funds may be used in other IDeA and non-IDeA
states for fee-for-service activities that include but are not limited to
activities such as learning new techniques, sample and data analysis, and
workshops. Whenever available, applicants should leverage, complement, and
interact with already existing institutional resources funded by the NIH and/or
other Federal or non-Federal entities.

Administrative
Core

Leadership
and Governance Plan

The administrative core oversees the overall governance and
organizational structure of the COBRE, including the functional relationships
between the Program Director/Principal Investigator (PD/PI), Program
Coordinator (PC), and the Directors of Core Resources, and between the COBRE
leadership and advisory committees. The efficient management of
institutional resources, the various cores and proposed center activities will
depend on a strong administrative core.

Program
Director/Principal Investigator (PD/PI) and Program Coordinator(s) (PC) of the
COBRE

The implementation of the activities detailed in the
application is the ultimate responsibility of the COBRE Program
Director/Principal Investigator (PD/PI). Multiple PDs/PIs are not
allowed. The PD/PI must be an established biomedical or behavioral
research scientist with demonstrated administrative leadership skills. As the
director of the COBRE, the PD/PI will establish the overall direction and
appropriate administrative structure of the center to support research efforts,
including the efficient management of component facilities and resources,
staffing and resource allocation, and for administering the award in accordance
with NIH policies. The PD/PI will be responsible for developing a pilot grants
program, selecting the core directors, resolving disputes arising in the usage
of the core facilities, and for final budget decisions. This person must
devote a minimum time commitment of 1.2 person months for the administrative
oversight of the COBRE. A maximum of 2.4 person months effort may be
supported.

The PD/PI may be assisted by Program Coordinator(s) with
administrative skills and experience that complement those of the PD/PI.
The PC(s) will provide day-to-day oversight of center operations and
administration, including assisting core directors to set work priorities, coordinating
recommendations for major purchases of supplies and equipment upgrades, recruitment
of technical support staff, and assisting in the resolution of other budget
issues with the core directors and the PD/PI. Each individual named as a
PC may devote 1.2 to 2.4 person months. The levels of effort specified
for the PD/PI and the PC(s) are required whether or not salary support is
requested. The PD/PI and the PC(s) are expected to attend a two-day biennial meeting
in Bethesda, Maryland with NIGMS staff.

Steering
and Advisory Committees

Steering Committee. Each Center will be directed by a
Steering Committee chaired by the PD/PI of the Center Grant. Members of
the committee will include the PC(s), directors of the individual Cores, and a senior
institutional official. Representation in the steering committee should
also come from the PD/PI(s) of research projects that utilize core resources. The
Steering Committee will establish guidelines to determine the most appropriate
methods for providing access to the Core facilities and services. The
Steering Committee will also advise the Center PD/PI on strategic and
operational issues, to maximize the impact of the Center on biomedical research
at the institution.

External Advisory Committee. The COBRE is required to
establish an External Advisory Committee (EAC) of 3-5 members that will meet at
least annually to review the structure and progress of the COBRE and to offer
recommendations to the PD/PI. An annual EAC report that summarizes discussions
at EAC meetings, recommendations made, and actions taken by the COBRE
leadership will be provided in yearly progress reports submitted to NIH.

Evaluation
Plan

The administrative core is tasked with overseeing an
internal evaluation plan for monitoring and documenting progress towards
achieving target goals and timelines. The Steering Committee is expected
to provide ongoing assessment and evaluation of the progress of the center.
Annual evaluation reports, including plans for any corrective actions, must be
provided to the EAC, Core Directors, other key personnel, institutional
stakeholders, and NIH Program Staff.

Scientific/Technical
Cores

The applicant may support already existing and/or new
research core facilities. Each proposed core must be well-justified and shown
to be essential in meeting the scientific requirements of projected users.
Consequently, the resources and services offered by each proposed core facility
must be adequate and appropriate in supporting ongoing and planned research
projects. Essential services for each core will include dissemination of core
capabilities, mentoring and training in new technology and modern
instrumentation, and providing scientific guidance in the design of research
proposals and experiments. Other essential components of each proposed core
are project prioritization and evaluation plans. Equally important, the
applicant must have sustainability plans for each proposed core beyond COBRE
III.

Sharing research resources among IDeA programs is strongly
encouraged. Applicants should seek to utilize existing equipment and
instrumentation supported by other COBRE or INBRE awards. Requests that appear
to be duplicative of existing equipment or instrumentation, including
computational facilities and related bioinformatics resources, must be
appropriately justified. Core facilities supported through this FOA must
not duplicate currently available facilities at the institution. Co-funding by
the applicant organization or by outside sources is encouraged.

Qualifications
and Responsibilities of Core Directors

Directors of research core facilities must be experienced
personnel with the requisite stature, knowledge, authority, leadership, and
administrative skills and capabilities to direct the resource. The Core
Director will lead a team of specialists in the specific area of service to:
(1) develop plans for standard operating procedures governing the utilization
and management of core expertise and resources, (2) develop plans for disseminating
information, training, and serving as subject matter experts to investigators,
(3) maintain state-of-the-art technologies and knowledge capabilities, and (4)
recommend to the COBRE PD/PI and PC any updates and/or replacement of equipment
or personnel. Each Director may devote 1.2 to 2.4 person months annually
to direct the core.

Core
Revenue

It is expected that the Cores will generate revenue via
fee-for-service arrangements whenever possible, in order to optimize efficient
resource usage and enhance resource sustainability.

Pilot
Grants Program

The COBRE must have a mechanism for soliciting and awarding
pilot research projects that allows junior or senior investigators to generate
preliminary data for submission of grant applications, develop new
technologies, and/or achieve other goals as defined by the PD/PI that will
better position the institution to conduct biomedical research. Up to
$250,000 annually can be used to support the pilot grants program. Pilot
projects cannot overlap with ongoing funded projects.

Research plans for individual pilot research projects should
not be included in the application. Principal investigators of pilot projects
must hold a faculty appointment or equivalent at the time the pilot award
commences. For the purposes of this FOA, these are individuals who can
independently apply for Federal or non-Federal investigator-initiated
peer-reviewed Research Project Grants (RPG). Individuals holding
postdoctoral fellowships or other positions that lack independent status are
not eligible to lead pilot projects.

Institutional
Commitment

While non-Federal matching funds are not required, the
application must show clear evidence of strong and specific institutional
commitment for the overall center and each center component. It is
recognized that the availability of resources is variable among
institutions. Consequently, the level of institutional commitment will
differ among applicant institutions. At a minimum, the application should
include in the Overall section communication from a senior institutional
official (e.g., President or Dean) outlining the resources and facilities that
will be committed by the institution to support and sustain the COBRE
throughout the period of funding and the commitment to maintain these resources
that will be made beyond the period of grant support. Some examples of
institutional commitments that may be documented include financial support,
adequate space, release time agreements, tenured or tenure-track positions for
faculty, FTEs for core facility personnel, and core consolidation and
maintenance.

Section II. Award
Information

Funding Instrument

Grant: A support mechanism providing money, property, or
both to an eligible entity to carry out an approved project or activity.

Limited Competition: Eligibility
is restricted to institutions with COBRE Phase II awards that are active on the
application due date.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible
to apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations
as described in the PHS 398 Application Guide to be eligible to apply for or
receive an award. Applicants must have a valid Dun and Bradstreet Universal
Numbering System (DUNS) number in order to begin each of the following
registrations.

System for
Award Management (SAM)– must maintain an active entity registration
(formerly CCR registration), to be renewed at least annually. Use the Sam.gov
“Manage Entity” function to manage your entity registrations. See the Grants
Registration User Guide at SAM.gov for additional information.

All Program Directors/Principal Investigators (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.

All registrations must be completed by the application due
date. Applicant organizations are strongly encouraged to start the registration
process at least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the
same as one already reviewed within the past thirty-seven months (as described
in the NIH
Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an
investigator-initiated application but not paid;

Of an investigator-initiated application that was originally
submitted to an RFA but not paid; or

Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Address to Request
Application Package

Applicants are required to prepare applications according to
the current PHS 398 application forms in accordance with the PHS 398
Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the PHS 398
Application Guide, except where instructed in this funding opportunity
announcement to do otherwise. Conformance to the requirements in the
Application Guide is required and strictly enforced. Applications that are out
of compliance with these instructions may be delayed or not accepted for review.

Application Submission

Applications must be prepared using the PHS 398 research
grant application forms and instructions for preparing a research grant
application. Submit a signed, typewritten original of the application,
including the checklist, and three signed photocopies in one package to:

All page limitations described in the PHS 398 Application
Guide and the Table of
Page Limits must be followed, in addition to the following page limitations
to the Research Strategy section of each component of the application.

All instructions in the PHS 398 Application Guide
must be followed, with the following additional instructions:

Annual total direct costs must not exceed $750,000. Only the
composite budget should be detailed here. Detailed budgets for each individual
component must not be included here but in the appropriate component.

Budget for Entire Proposed Period of
Support (Overall)

All instructions in the PHS 398 Application Guide
must be followed.

Biographical Sketch (Overall)

All instructions in the PHS 398 Application Guide
must be followed, with the following additional instructions:

Biographical sketches are required for all key personnel
participating in COBRE activities. Compile all biographical sketches starting
with the overall Program Director/Principal Investigator (PD/PI) followed by
all other professional and administrative staff involved in the operations of
the COBRE, arranged in alphabetical order. Do not repeat biographical sketches
in the individual sections for the administrative and scientific/technical cores
or pilot grants program.

Resources (Overall)

All instructions in the PHS 398 Application Guide
must be followed.

Research Plan (Overall)

All instructions in the PHS 398 Application Guide
must be followed, with the following additional instructions:

Introduction
(Resubmission Applications Only): The Introduction must include
responses to the criticisms and issues raised in the prior Summary Statement.
Summarize the substantial additions, deletions, and changes. Identify within
the Research Strategy the changes made by clearly bracketing, indenting, or
changing typography, unless the changes are so extensive as to include most of
the text. This exception should be explained in the Introduction. Do not
underline or shade changes.

Specific
Aims: Required

Research
Strategy: Provide details of the overall center organization
and management plan that includes the following:

Major progress and accomplishments made in the last 10 years of
COBRE support (Phases I and II) in the following areas:

Research productivity as measured by scientific
publications in peer reviewed journals and presentations at scientific meetings
and other conferences.

Research grants submitted to and awarded by NIH
or other funding agencies.

Improvement of research infrastructure as
measured by utilization of core facilities by COBRE and non-COBRE
investigators, and increased research productivity associated with core
support.

Other metrics as defined by the applicant that
demonstrate accomplishments during the last 10 years of COBRE support.

The organizational structure of the COBRE and overall strategic
plan for achieving the overall specific aims of the center

The scientific opportunities that the center intends to pursue
over the next five years and beyond

Justification for the cores and facilities that will be
supported and the proposed plans to promote and ensure their sustainability
beyond COBRE phase III, The host institution’s existing facilities and
available services should be clearly delineated from the facilities and
services that are proposed for funding via this FOA in the “Resources” section
of the application (see Section
IV. Application and Submission Information

Summary of the projected center participants, their respective
projects, and their anticipated scientific and core facility needs.

Bibliography
and References Cited/Progress Report Publication List: Include
allpublications
produced in COBRE Phases I and II.

Letters
of Support: Applicants must provide letters from the
appropriate high-ranking institutional official(s) that defines the financial
and other resource support for the COBRE that will be provided by the
institution. There are no dollar requirements, but specific commitment is
required.

As appropriate, letters from the Program
Directors/Principal Investigators of other awardees of NIH and other Federal
and non-Federal entities (e.g., INBREs, COBREs, CTSAs) may be included
indicating their program’s role in supporting the COBRE's goals and proposed activities
for achieving sustainability.

All instructions in the PHS398 Application Guide must be
followed, with the following additional instructions, as noted.

Face Page (Administrative Core)

All instructions in the PHS 398 Application Guide
must be followed, with the following additional instructions:

Only Items 1 and 3a should be completed. Item 1 (Title of
Project) should indicate 'Administrative Core'. Item 3a (Name of PD/PI) should
indicate the individual who will direct the core. All other items should be
left blank.

All instructions in the PHS 398 Application Guide
must be followed, with the following additional instructions:

Key personnel for the Administrative Core include the PD/PI, Program
Coordinator(s), and other professional and administrative staff involved in the
operations of the administrative core. Only those individuals for whom salary
support is requested must be included.

Table of Contents (Administrative
Core)

All instructions in the PHS 398 Application Guide
must be followed.

Detailed Budget for Initial Budget
Period (Administrative Core)

All instructions in the PHS 398 Application Guide
must be followed. Each individual named as a PD/PI or PC may devote 1.2 to 2.4
person months effort whether or not salary support is requested. If items
normally treated as F&A costs are requested as direct costs (for example,
computers and general office supplies), the applicant must provide a strong
justification for those items and demonstrate that the cost is commensurate
with the benefit that that particular item will have on the associated project.

Budget for Entire Proposed Period of
Support (Administrative Core)

All instructions in the PHS 398 Application Guide
must be followed.

Biographical Sketch (Administrative Core)

All Biographical Sketches must be included in the
Overall Center Organization and Management Plan component.

Resources (Administrative Core)

All instructions in the PHS 398 Application Guide
must be followed.

Research Plan (Administrative Core)

All instructions in the PHS 398 Application Guide
must be followed, with the following additional instructions:

Introduction
(Resubmission Applications Only, one page limit): The
Introduction must include responses to the criticisms and issues raised in the
prior Summary Statement. Summarize the substantial additions, deletions, and
changes. Identify within the Research Strategy the changes made by clearly
bracketing, indenting, or changing typography, unless the changes are so
extensive as to include most of the text. This exception should be explained in
the Introduction. Do not underline or shade changes.

Specific
Aims: Required

Research
Strategy: The Research Strategy for the Administrative Core
must provide details of the following:

Implementation plans for accomplishing the proposed specific
aims, including the management, coordination, and supervision of the entire
range of center activities. An explicit discussion of how fiscal and other
resources will be prioritized, allocated, and managed must be provided.

Qualifications and responsibilities of the PD/PI, and Program
Coordinator(s).

The policies and procedures that will govern the administrative
and scientific operations of the COBRE, including the structure for
decision-making on several levels (e.g., COBRE PD/PI and PC(s), Core
Director(s), steering committee, external advisory committee, and COBRE
investigators), and how each member of the COBRE would participate in the
decision making process.

Operational plans that will govern the COBRE leadership's
interactions with the proposed cores, advisory committees, and aligned
investigators.

Membership, functions, and responsibilities of Steering and
Advisory Committees. The areas of expertise and requisite qualifications of
EAC members and their terms of service must be clearly defined and
appropriately aligned with the objectives of the Center. The application must
provide functional and operational details of the duties and responsibilities
of the group. Plans must be included as to how recommendations of advisory
committees are secured, considered and, as appropriate, implemented by the
COBRE leadership.

Evaluation strategies that will be employed to assess core performance
and achievements. Objective criteria and concrete metrics must be provided that
include qualitative and quantitative measures of core usage, research
productivity, scientific/technical breakthroughs, and revenue generation.

Institutional plans for ensuring compliance with all regulatory
guidelines pertaining to the protection of human subjects, and the care and
welfare of vertebrate animals involved in research.

Applicants are instructed to generate a separate application
component for each proposed Scientific/Technical Core. All instructions in the
PHS398 Application Guide must be followed, with the following additional
instructions, as noted.

Face Page (Scientific/Technical Core)

Using PHS 398 Face Page form, only the following
items should be completed: Item 1 (Title of Project) should indicate the name
of the Core. Item 3a (Name of PD/PI) should indicate the individual who will
direct the core. Items pertaining to human subjects and vertebrate animals
must be completed accordingly. All other items should be left blank.

All instructions in the PHS 398 Application Guide must
be followed. Key personnel for the core include the Core Director,
co-Director(s), and other professional and administrative staff involved in the
operations of the core. Only those individuals for whom salary support is
requested must be included.

Table of Contents (Scientific/Technical
Core)

All instructions in the PHS 398 Application Guide
must be followed.

Detailed Budget for Initial Budget
Period (Scientific/Technical Core)

All instructions in the PHS 398 Application Guide
must be followed. Each Director may request 1.2 to 2.4 person months annually
to direct the core. If items normally treated as F&A costs are requested
as direct costs (for example, computers and general office supplies), the
applicant must provide a strong justification for those items and demonstrate
that the cost is commensurate with the benefit that that particular item will
have on the associated project.

Budget for Entire Proposed Period of
Support (Scientific/Technical Core)

All instructions in the PHS 398 Application Guide
must be followed.

Biographical Sketch (Scientific/Technical
Core)

All Biographical Sketches must be included in the
Overall Center Organization and Management Plan component.

Resources (Scientific/Technical Core)

All instructions in the PHS 398 Application Guide
must be followed.

Research Plan (Scientific/Technical Core)

All instructions in the PHS 398 Application Guide
must be followed, with the following additional instructions:

Introduction
(Resubmission Applications Only): The Introduction must include
responses to the criticisms and issues raised in the prior Summary Statement.
Summarize the substantial additions, deletions, and changes. Identify within
the Research Strategy the changes made by clearly bracketing, indenting, or
changing typography, unless the changes are so extensive as to include most of
the text. This exception should be explained in the Introduction. Do not
underline or shade changes.

Specific
Aims: Required

Research
Strategy : The Research Strategy section for each proposed
scientific or technical core must provide details of the following:

Core description and justification

Qualifications, roles, and responsibilities of Core director(s)
and staff. Include information on scientific and administrative skills of core
leadership.

Operating procedures of the core:

Maintenance of state-of-the-art techniques and
quality controls

Mentoring and training of investigators in the
capabilities of the core

Allocation of core budgets

Process for reviewing, prioritizing, and
supporting projects. The project prioritization plan must include description
of how the capacity and services of the proposed Core will be evaluated and
allocated by the Steering Committee. For example, prioritization may be
established by virtue of a differential fee structure or by a formal project
evaluation mechanism.

Resolution of disputes relating to core usage

Fee-for-service arrangements and procedures for
waiver.

Sources of Support for the Core. For existing cores, the
following Table must be provided:

Income Source

Current Support ($)

Percent of Current Total Budget

Proposed Support - Year 1 ($)

Percent of Proposed Total Budget

COBRE

Fee for Service/ Chargebacks

Other (specify sources, add additional lines as needed)

Total Operating Budget

Evaluation strategies to determine efficiency and effectiveness
of the core, including mechanisms for tracking utilization of core resources
and for adapting to the needs of investigators.

Strategic plans for sustaining the core beyond COBRE Phase III.

Research pool and scientific projects that will utilize the
resources in the core

Summary of specific institutional commitments to support the
core.

Bibliography
and References Cited

Letters
of Support: Applicants must provide letters from the
appropriate high-ranking institutional official(s) that specifies the financial
and other resource support for the core that will be provided by the
institution. There are no dollar requirements, but specific commitment is required.

As appropriate, letters from the Program
Directors/Principal Investigators of other awardees of NIH and other Federal
and non-Federal entities (e.g. INBREs, COBREs, CTSAs) may be included
indicating their program’s role in supporting the core. When applicable,
applicants should include letters which indicate how the core will leverage,
complement, or interact with existing institutional resources funded by NIH or
other Federal or non-Federal entities.

All instructions in the PHS398 Application Guide must be
followed, with the following additional instructions, as noted.

Face Page (Pilot Grants Program)

Using PHS 398 Face Page form, only the following
items should be completed. Item 1 (Title of Project) should indicate 'Pilot
Grants Program'. Item 3a (Name of PD/PI) should indicate the individual who
will direct the Program. All other items should be left blank.

All instructions in the PHS 398 Application Guide
must be followed. The budget for the Pilot Grants Program must not exceed
$250,000 per year.

Budget for Entire Proposed Period of
Support (Pilot Grants Program)

All instructions in the PHS 398 Application Guide
must be followed.

Biographical Sketch (Pilot Grants
Program)

All Biographical Sketches must be included in the
Overall Center Organization and Management Plan component.

Resources (Pilot Grants Program)

All instructions in the PHS 398 Application Guide
must be followed.

Research Plan (Pilot Grants Program)

All instructions in the PHS 398 Application Guide
must be followed, with the following additional instructions:

Introduction
(Resubmission Applications Only): The Introduction must include
responses to the criticisms and issues raised in the prior Summary Statement.
Summarize the substantial additions, deletions, and changes. Identify within
the Research Strategy the changes made by clearly bracketing, indenting, or
changing typography, unless the changes are so extensive as to include most of
the text. This exception should be explained in the Introduction. Do not
underline or shade changes.

Specific
Aims: Required

Research
Strategy: The Research Strategy section for the Pilot Grants
Program should include the following:

A plan for the solicitation of proposals, prioritization of the
projects, and the review of their methodology and research performance.

The plans for defining the scope of the projects, eligibility
requirements, the limit on the dollars available, and the number of years of
support per project.

Governance, oversight, and evaluation procedures that include the
EAC.

If a pilot grants program has previously been in place during
COBRE I and II, the applicant must provide data on the effectiveness of
dissemination and review process of the program including number of applicants
and awardees per cycle, how many outside grant applications were submitted by
pilot investigators and how many were funded, publications resulting from pilot
projects, any scientific/technical breakthroughs. The potential pool of
qualified investigators from whom to solicit applications. Research plans for
individual pilot projects should not be included in the application.

Letters
of Support: Applicants must provide letters from the
appropriate high-ranking institutional official(s) that specifies the financial
and other resource that will be provided by the institution for the COBRE's
Pilot Grants Program. There are no dollar requirements, but specific
commitment is required.

Research
involving human subjects and/or vertebrate animals: Institutional
process(es) in place to assure that all pilot projects supported by this awards
will comply fully with all applicable federal policies, rules, and guidelines
for research involving human subjects and/or vertebrate animals.

Appendix for the Entire Application

Do not use the Appendix to circumvent page limits. Follow
all instructions for the Appendix (please note all format requirements) as
described in the PHS 398 Application Guide.

Applications must be received on or before the due date
specified in Part I. Overview Information.
If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review. Applications that are
incomplete will not be reviewed.

Post-Submission Materials

Applicants are required to
follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the COBRE center to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
COBRE center proposed).

Scored Review Criteria - Overall Center Application

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a Center that by its nature is not
innovative may be essential to advance a field.

Significance

Does the center address an important problem or a
critical barrier to progress in the field? If the aims of the center are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Are the Center's vision and strategy adequate to
facilitate and sustain high-caliber research in the institution?

Progress
and Accomplishments. Has previous support allowed the center
to achieve specific benchmarks, which include the acquisition of independent
status by the junior investigators, publishing data in peer-reviewed journals,
and evidence that the competitiveness of these investigators for other NIH,
Federal or non-Federal external peer-reviewed research grant support has been
enhanced? Is there evidence that a critical mass of investigators has been (or
is being) established? Have new investigators been recruited to the center and
have these efforts been successful in increasing the biomedical or behavioral
research capacity of the institution? Is there evidence that the scientific
cores supported by COBRE funds were sufficiently utilized and were instrumental
in enhancing productivity of investigators associated with the COBRE? Is there
evidence that the COBRE enhanced diversity of the scientific workforce?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the Center? If Early Stage Investigators or New
Investigators, or in the early stages of independent careers, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the
project is collaborative or multi-PD/PI, do the investigators have
complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the Center?

Leadership:
Does the PD/PI have the ability to provide scientific and administrative
leadership and direction? Have the PD/PI and PC(s) proposed adequate time
commitment to effectively manage the Center? Has the PD/PI shown effective
leadership and judgment in the selection of research cores in terms of the cores
being related to and consistent with the overall goals of the center? Has the
PD/PI presented a plan to develop and maintain core laboratories as
state-of-the-art through the selection of appropriate Core Directors?

Program
coordinator/manager(s): Does the program coordinator/manager
have the requisite background and knowledge that complement the PD/PI's with
respect to managing core resources and overall operation of the Center? Has
he/she demonstrated an ability to oversee and coordinate research activities?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Is the center positioned to develop new approaches to
increasing the ease and efficiency of conducting research by the investigators
associated with the COBRE? Is there a well-designed and innovative plan for
enhancing communication, coordination and collaboration among Center
Investigators and the proposed cores?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the center?
Are potential problems, alternative strategies, and benchmarks for success presented?
If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human
subjects from research risks, and 2) inclusion of minorities and members of
both sexes/genders, as well as the inclusion of children, justified in terms of
the scientific goals and research strategy proposed?

Is the management plan appropriate for fiscal
administration, resource procurement, property and personnel management,
planning, and budgeting? Has the PD/PI presented a well-thought out plan for
achieving sustainability of the cores beyond COBRE III?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique features
of the scientific environment, subject populations, or collaborative
arrangements?

Is the institutional environment supportive and
conducive for achieving the objectives of the COBRE? Are there effective lines
of communication and cooperation among the COBRE leadership, aligned
investigators, Core Directors and Staff, and Institutional Leadership?

Additional Review Criteria for Components

In addition to the above criteria, the following components
of the COBRE Phase III application will be scored independently AND will be
considered in the determination of the overall impact/priority score for the
whole application.

Administrative Core

Reviewers will consider the following criteria in the
determination of an impact score for the Administrative Core, although scores
for the individual criteria will not be provided.

Governance. Is the
governance structure designed to ensure the optimal operations and
accountability of the cores that comprise the COBRE? Is the COBRE guided by an
appropriately constituted External Advisory Committee? Are appropriate and
well-defined responsibilities described for the PD/PI, PC(s), Steering
Committee, External Advisory Committee, Research Core Directors, and other
involved parties? Are the lines of administrative responsibilities
within the COBRE and the relationships between the PD/PI, PC(s), and the Core
Directors clearly delineated?

Communication.
Are the proposed dissemination and communication plans adequate for reaching a
wide range of investigators and promoting expansion of the pool of users of the
Core facilities?Are there adequate plans for establishing communication lines
between the COBRE leadership and the External Advisory Committee and
Institutional Leaders?

Evaluation. Are there
adequate plans for objectively evaluating the operations and activities of the
Center by the COBRE leadership, with input from the Steering and External
Advisory Committees? Has the applicant provided evaluation plans with feasible
objectives, and detailed quantitative and/or concrete criteria for assessing
core effectiveness and efficiency? How will the recommendations of the
Steering and External Advisory Committees be integrated into the effective
fiscal, personnel and scientific management of the COBRE over the course of the
grant award?

Scientific/Technical Cores

Reviewers will consider the following criteria in the
determination of an impact score for each proposed Scientific/Technical Core,
although scores for the individual criteria will not be provided.

Need: Does the Core
provide services and/or resources that meet the scientific needs of the
projected COBRE research base? What is the likelihood that the Core
will increase efficiency, accelerate progress, and promote new research
directions for investigators in the institution? Is there a significant pool
of researchers and projects that will utilize the resources of the core? For
requests of new core facilities, is the request well justified in terms of the
need for the core?

Operations: Are the
services and resources provided by the Core likely to drive science with
increasingly sophisticated and powerful technologies and evolve with the
science conducted by the Center Investigators? Is the core structured to
allow the development of novel concepts, approaches, and methodologies? Are
the services and resources of the Core of high quality and do they provide
advanced techniques and services? Are quality control measures and
procedures in place to ensure quality and consistency of services and resources?
Are plans and procedures in place to ensure maintenance of cores as
state-of-the-art facilities and the resolution of disputes of core usage? Is
the Core cost-effective in providing services and resources to the Center
investigators? Will resource utilization be tracked and mechanisms in
place to adapt resources to the needs of investigators? Does the Core
effectively leverage existing resources at the institution? Has the applicant
provided adequate sustainability plans for the core beyond COBRE III?

Personnel: Are the
qualifications, experience, and commitment of the Core Director and other core
staff appropriate to the proposed scientific/technical area? Has the core
leadership demonstrated expertise in the core technologies by specific training
and/or publications using such methods and equipment? Do the core leadership
and personnel have experience in mentoring and research training investigators
who use the cores? Are staff members of sufficient numbers and adequate
training to support the needs of the projected pool of COBRE investigators? Do
these individuals dedicate sufficient time?

Evaluation: Is there
an adequate plan in place to evaluate core performance?

Pilot Grants Program

Reviewers will consider the following criteria in the
determination of an impact score for the Pilot Grants Program, although scores
for the individual criteria will not be provided.

Significance: Is the
Pilot Grants Program well integrated into the overall goals and objectives of
the COBRE? If the pilot grants program has been in existence in the previous
COBRE phases, how effective has it been?

Investigators/Reviewers:
Are the plans for constituting the review panel, their qualifications and
expertise, appropriate to evaluate pilot project applications?

Innovation: Is the
program structured to allow the development of novel concepts, approaches, and
methodologies?

Approach: Is there an
adequate plan to solicit applications, to prioritize the projects, and to
review research performance? Are plans adequate to assure compliance with
applicable federal policies and guidelines for research and research
protections, and to review their methodology?

Environment: Does the
institution have a sufficient pool of qualified investigators from whom to
solicit applications?

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and
Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by NIGMS, in
accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications will receive a written
critique.

Applications will be assigned to the appropriate NIH
Institute or Center and will compete for available funds with all other
recommended applications . Following initial peer review, recommended applications
will receive a second level of review by the NIGMS Advisory Councill. The
following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

Awardee-selected projects require approval by NIH prior to
initiation (see the NIH Grants Policy Statement 8.1.3
Requests for Prior Approval for instructions on submitting a request). The
awardee institution will provide NIH with the following documents for review:

Copy of the full research proposal.

Written evaluation of the scientific and technical merit of the
project by the review panel and funding recommendation by the COBRE External Advisory
Committee.

When multiple years are involved, awardees will be required
to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR)
annually and financial statements as required in the NIH
Grants Policy Statement.

A final progress report, invention statement, and the
expenditure data portion of the Federal Financial Report are required for
closeout of an award, as described in the NIH
Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and
405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.